Status:
COMPLETED
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cardiac Transplantation
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduc...
Eligibility Criteria
Inclusion
- Male or female cardiac recipients over 18 years old
- First or second heart transplant, more than one year following surgery
- Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
Exclusion
- Current CNI-free immunosuppressive regimen
- Patients currently or previously treated with a mTOR inhibitor any time prior randomization
- Patients who are recipients for a multiple solid organ transplant
- Treated acute rejection episode within three months prior randomization
- Congestive heart failure (NYHA class III or IV) and/or VEF \< 30 % and/or patient waiting for a re-transplantation
- Scheduled surgical intervention
- Platelet count \< 50 G/l
- Severe hepatic insufficiency (SGPT and/or SGOT \> 3N)
- Major lipidic profile abnormalities (total cholesterol \> 3g/l and/or TG \> 5g/l)
- Proteinuria/creatinuria \> 0,08 g/mmol
- Severe renal failure attested by cGFR \< 30 ml/min/1.73m² (MDRD4)
- History of Hypersensitivity to everolimus, sirolimus or excipients
- History of Hypersensitivity to macrolides
- Pregnancy and breast feeding
- Childbearing age women without efficient contraception
- Law protected patients
- Patients in emergency unable to express their consent
- History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
- History of Hypersensitivity to tacrolimus, macrolides or excipients
- History of Hypersensitivity to azathioprine
- History of Hypersensitivity to mycophénolate mofetil or excipients
Key Trial Info
Start Date :
September 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00716573
Start Date
September 16 2008
End Date
April 17 2014
Last Update
June 20 2017
Active Locations (1)
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1
Hospices Civils de Lyon
Lyon, France